On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
5/12/2023
/ Artificial Intelligence ,
Center for Drug Evaluation and Research (CDER) ,
Comment Period ,
Digital Health ,
Food and Drug Administration (FDA) ,
Governance Standards ,
Machine Learning ,
Medical Devices ,
National Evaluation System for Health Technology (NEST) ,
NIST ,
Transparency
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments."...more
The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820)...more